A Randomized, Double-Blind, Bilateral Comparison Study of the Safety and Efficacy of 10XB-101 in Adult Subjects With Bilateral Flank Adiposity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 10xBio, LLC
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Volumetric measurements
研究概览
简要总结
The goal of this clinical trial is to test the safety and effectiveness of an injection study drug in decreasing bilateral flank adiposity.
The main question it aims to answer is:
•How safe and effective is the injection study drug in removing bilateral flank adiposity compared to a placebo?
Participants will be:
- Be given injections every month for 5 months over the right and left flanks.
- Be asked to be seen in the clinic for 13 visits and 3 phone call visits during a duration of 1 year.
详细描述
Fifteen subjects with bilateral flank adiposity will be enrolled across 1-3 sites in the USA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
1:1 ratio
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a male or non-pregnant female 18 to 55 years old.
- •Subject has provided written informed consent.
- •Subject has qualifying fat evaluation and skin laxity scores on each right and left flanks.
- •Subject has had a stable body weight for the past 6 months prior to starting study.
- •Subject is willing to undergo test article injections as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has loose skin in the right and left flank areas, unrepaired abdominal injury or defect, scars, tattoos, or other features that may interfere with evaluation of localized fat, in the opinion of the investigator.
- •Subject has any medical condition or taking medications that affects clotting and/or platelet function
- •Subject has a history of allergy or sensitivity to polidocanol or any of the other ingredients in the test articles.
研究组 & 干预措施
10XB-101 Solution for Injection, 6.0%
Participants receive 10XB-101 Solution for Injection, 6.0% via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.
干预措施: 10XB-101 Solution for Injection, 6.0% (Drug)
Placebo Solution for Injection
Participants receive Placebo Solution for Injection, via subcutaneous injection up to 10 mL. Injection treatment will occur once every 4 weeks for up to 6 treatments.
干预措施: Placebo Solution for Injection (no active ingredient) (Drug)
结局指标
主要结局
Volumetric measurements
时间窗: 24 weeks after final injection treatment
Change from Baseline until end of study. Volumetric measurements will be obtained on each right and left flanks thru a standard photographic assessment.
Patient Global Impression of Change (PGIC)
时间窗: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Patient Global Impression of Change (PGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
Flank Skin Laxity Scale (FSLS)
时间窗: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Flank Skin Laxity Scale (FSLS) is a 4 point scale, with a score of 0 for no skin folds, and a score of 3 for severe or worse skin folds.A higher score means a worse outcome.
Clinician Global Impression of Change (CGIC)
时间窗: 24 weeks after final injection treatment
Change from Baseline on each flank after final treatment. Clinician Global Impression of Change (CGIC) is a 7-point bi-directional scale with 1 as much improved and 7 as much worse.
次要结局
未报告次要终点